Z-1275-2022Class II

EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the...

Name: Z-1275-2022 EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the...
Creator: Olympus Corporation of the Americas
Published: 2022-04-22
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2022-04-22 / Open, Classified / root cause: manufacturing process

FDA source

Olympus Corporation of the Americas began a recall of EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190 on 2022-04-22. FDA classified it as Class II and gives the reason as "Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Olympus. An Incorrect A-rubber fits tighter on the GIF-HQ190...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1275-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-04-22
Posted: 2022-06-21
Recalling firm: OLYMPUS Corporation of the Americas
Product: EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190
Product code: FDS Gastroscope And Accessories, Flexible/Rigid
Reason for recall: Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Olympus. An Incorrect A-rubber fits tighter on the GIF-HQ190 which would not meet the intended design specifications
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Olympus issued Urgent Medical Device Correction letter via email on 4/22/22. Letter states reason for recall, health risk and action to take: 1. Identify the affected model and serial number in the subject of this letter. 2. An Olympus representative will contact you to arrange for the return of your affected device. Olympus will repair your unit free of charge. 3. Olympus will provide for a service loaner in an effort to not disrupt patient care. Please do not hesitate to contact @ 647-999-3203 or at [email protected] for any additional information or support concerning this matter.
Quantity in commerce: 8 units
Distribution: US Nationwide distribution in the states of AL, FL, NC, NY.
Product codes and lots: UDI-DI: 04953170305276 Serial: 2269931, 2611873, 2613235, 2634251, 2634326, 2860721, 2961773 and 2962545

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1275-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1275-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-29	2022-06-21

Product code FDS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)